Drug factory · FDA FEI 3000225055

Juzen Chemical Corporation

1-10 Kiba-machi, Toyama-city, Japan

Problems found, fixed voluntarily at FDA's last inspection, Aug 1, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Fezolinetant	Makes the active ingredient and tests it	Astellas Pharma US, Inc.	0469-2460, 0469-2660, 0469-2760
Metformin and Pioglitazone	Makes the active ingredient	Takeda Pharmaceuticals America, Inc.	64764-158
Pegcetacoplan	Makes the active ingredient	Apellis Pharmaceuticals, Inc.	73606-010, 73606-020

Ended	Result	Program	Problems noted
Aug 1, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 7, 2019	No problems found	Drug Quality Assurance	—
Mar 9, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	3
Mar 4, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 1, 2012	No problems found	Drug Quality Assurance	—
Jul 7, 2009	No problems found	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing.
Defined areas of adequate size for operations 21 CFR 211.42(c)
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Registered with FDA for: analysis; api manufacture.